BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM

    MDR report key: 4100451 · Received September 19, 2014

    Report

    Report Number
    0009610622-2014-00486
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    December 24, 2013
    Report Date
    December 11, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. THE NAIL AND ALL SCREWS WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR).THE IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION OF THE IMPLANTS THEMSELVES WAS NOT POSSIBLE BECAUSE THEY WERE NOT AVAILABLE. BASED ON THE PROVIDED INFORMATION TWO ISSUES WERE IDENTIFIED; FIRST AN INFECTION WITH (B)(6) AND SECOND AN ALLERGIC REACTION. BOTH ISSUES WERE REVIEWED AND EVALUATED BY A MEDICAL EXPERT: TO INFECTION WITH (B)(6): (B)(6) REPRESENTS A SUBGROUP OF STAPHYLOCOCCUS AUREUS, WHICH IS RESISTANT AGAINST MOST COMMON ANTIBIOTICS. THIS GERM IS A TYPICAL HOSPITAL GERM; THE OCCURRENCE DURING THE MANUFACTURING PROCESS IS EXCLUDED WITH A PROBABILITY BORDERING ON CERTAINTY. FURTHERMORE, THE REVIEW OF THE DHR SHOWED THAT ALL IMPLANTS WERE SUCCESSFULLY STERILIZED WITH GAMMA RADIATION; THEREFORE IT IS GRANTED THAT THE IMPLANTS WERE DELIVERED IN STERILE CONDITION. STERILIZED STRYKER IMPLANTS ARE GRANTED TO BE STERILE FOR FIVE YEARS (AS VISIBLE ON THE LABEL) IF THE PACKAGING IS UNDAMAGED. THE REVIEW OF THE LABELS INDICATES THAT ALL IMPLANTS WERE USED PRIOR TO THEIR EXPIRY DATES AND NO REPORT CONCERNING A DAMAGED PACKAGING OF THE AFFECTED DEVICES HAS BEEN CONVEYED TO STRYKER. THUS, CONTAMINATION AT THE MANUFACTURER¿S SITE IS EXCLUDED WITH A PROBABILITY BORDERING ON CERTAINTY. TO ALLERGIC REACTION: THE PATIENT STATED THAT ¿SHE IS ALLERGIC TO TITANIUM¿. THE USED IMPLANTS ARE MADE OF ANODIZED TITANIUM ALLOY (B)(4). IN CONTRAST TO IMPLANTS MADE FROM STAINLESS STEEL ALLOYS, WHICH ARE KNOWN TO HAVE POTENTIAL ALLERGIC REACTIONS (MAINLY TO NICKEL AND CHROMIUM) THERE IS NO EVIDENCE IN THE SCIENTIFIC LITERATURE WORLDWIDE REPORTING OR CONFIRMING ANY ALLERGIC REACTION TO PURE TITANIUM OR MEDICAL GRADE TITANIUM ALLOYS; THEREFORE, THIS ISSUE CAN ALSO BE EXCLUDED WITH A PROBABILITY BORDERING ON CERTAINTY. IT IS REPORTED THAT THE PATIENT IS ALLERGIC TO MORPHINE. FURTHERMORE THE PATIENT GOT SEVERAL MEDICAMENTS LIKE ANTIBIOTICS (E.G. BACTRIM AND KEFLEX). THE NOMINATED ALLERGIC SYMPTOMS ARE VERY TYPICAL FOR A DRUG ERUPTION. THEREFORE IT IS VERY LIKELY THAT THE ALLERGIC REACTION WAS CAUSED BY INTOLERANCE TO ONE OR SEVERAL APPLIED MEDICAMENTS. THUS, A RELATIONSHIP TO THE STRYKER IMPLANTS THAT ARE MADE FROM TITANIUM ALLOY IS EXCLUDED WITH A PROBABILITY BORDERING ON CERTAINTY. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    PATIENT REPORTS THAT THEY FELL IN (B)(6) OF 2013 AND HAD A ROD IMPLANTED IN THERE TIBIA AND FIBULA. IN THE BEGINNING OF APRIL THERE LEG STARTED TO ITCH WHICH THEN STARTED TO SPREAD ALL OVER THERE BODY. ALSO REPORT, WHEN THERE BOOT CAME OFF THERE WAS A STAPH INFECTION WHICH WAS TREATED BY A DERMATOLOGIST. PATIENT ALSO STATED THAT SHE IS ALLERGIC TO TITANIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584744 LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K07FA29

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention